QMS Standards, Regulatory Certifications, Accreditations, Licenses

Infinity Laboratories maintains updated regulatory information relevant to each site (e.g DEA, FDA, ISO 17025)
Home > Quality

Castle Rock, CO – Headquarters

FDA FEI# 1000517789 DUNS# 67754506 Renewal December 31st

ISO 17025 Certificate (ANAB)

Recognized standard demonstrating competency to carry out tests and/or calibrations, including sampling. It ensures accredited laboratories have demonstrated technical proficiency and that the data produced is both accurate and precise. The laboratory’s quality management system has been thoroughly evaluated to guarantee continued technical competency and compliance.

Download Document

DEA License

A license issued by the Drug Enforcement Agency demonstrating compliance with agencies requirement for tracking and handling of controlled substances.

Download Document

Quality Policy

Download Document

Petaluma, CA

FDA FEI# 3018980151 DUNS# 90678446 Renewal December 31st

ISO 9001:2015

Recognized standard demonstrating competency in Quality Management System. The laboratory’s quality management system has been thoroughly evaluated for compliance.

Download Document

Change Notification

Download Document

San Diego, CA

FDA FEI# 3017099224 DUNS# 11950840 Renewal December 31st

ISO 17025 Certificate (ANAB)

Recognized standard demonstrating competency to carry out tests and/or calibrations, including sampling. It ensures accredited laboratories have demonstrated technical proficiency and that the data produced is both accurate and precise. The laboratory’s quality management system has been thoroughly evaluated to guarantee continued technical competency and compliance.

Download Document

North Brunswick, NJ – Calibration & Instrumentation Services

Change Notification

Download Document

ISO 17025 Certificate (ANAB)

Recognized standard demonstrating competency to carry out tests and/or calibrations, including sampling. It ensures accredited laboratories have demonstrated technical proficiency and that the data produced is both accurate and precise. The laboratory’s quality management system has been thoroughly evaluated to guarantee continued technical competency and compliance.

Download Document

San Jose, CA (Package Testing)

Change Notification

Download Document

ISO/IEC 17025:2017

Recognized standard demonstrating competency to carry out tests and/or calibrations, including sampling. It ensures accredited laboratories have demonstrated technical proficiency and that the data produced is both accurate and precise. The laboratory’s quality management system has been thoroughly evaluated to guarantee continued technical competency and compliance.

Download Document

San Jose, CA (Sterilization Services)

ISO 13485:2016

Requires a quality management system standard to demonstrate its ability to provide medical devices and related services (sterilization) that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production (sterilization), storage and distribution, installation, or servicing of a medical device and design and development or provision of

Download Document

FDB License

State of California Medical Device Manufacturing License

Download Document

FDA Registration

Download Document

BAAQ Permits to Operate

Bay Area Quality Management District requires up to date permitting for Ethylene Oxide related equipment to preserve air quality.

Download Document

QSM Quality Policy

Download Document

New Customer EO Inquiry Product Form

Download Document

Change Notification

Download Document

Crown Point, IN

FDA FEI 3008580332 DUNS# 118120524 Renewal December 31st

Change Notification

Download Document

DEA License

A license issued by the Drug Enforcement Agency demonstrating compliance with agencies requirement for tracking and handling of controlled substances.

Download Document

Indiana Pharmacy Board Controlled Substance Registration

Download Document

North Brunswick, NJ – dba Advanced Analytical Testing Laboratories

FDA FEI 3007270600 DUNS# 27361249 Renewal December 31st

ISO 17025

Recognized standard demonstrating competency to carry out tests and/or calibrations, including sampling. It ensures accredited laboratories have demonstrated technical proficiency and that the data produced is both accurate and precise. The laboratory’s quality management system has been thoroughly evaluated to guarantee continued technical competency and compliance.

Download Document

St. Louis, MO – dba DYNALABS, LLC

FDA FEI 3005115360 DUNS# 159008619 Renewal December 31st

ISO 17025

Recognized standard demonstrating competency to carry out tests and/or calibrations, including sampling. It ensures accredited laboratories have demonstrated technical proficiency and that the data produced is both accurate and precise. The laboratory’s quality management system has been thoroughly evaluated to guarantee continued technical competency and compliance.

Download Document

DEA License

A license issued by the Drug Enforcement Agency demonstrating compliance with agencies requirement for tracking and handling of controlled substances.

Download Document

BNDD

A license issued by the state to handle narcotics. This is required to request a Drug Enforcement Agency license.

Download Document

Lewisville, TX – (Coming Soon)

Contact us today

Experience how Infinity Laboratories
goes Beyond Testing to meet your needs

Contact us